Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anne Klibanski, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00140842
First received: August 30, 2005
Last updated: October 3, 2011
Last verified: September 2011
  Purpose

This study will examine hormonal differences in ghrelin and growth hormone in obese and normal weight adolescents and their relationship to body composition and insulin resistance. The study will also investigate the effect of the macronutrient composition of a meal on postprandial ghrelin levels and whether ghrelin responses will predict the degree of hunger and caloric intake at a subsequent meal.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Peak Growth Hormone (GH) on the GH Stimulation Test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Peak growth hormone (GH) on the GH stimulation test is a measure of the adequacy of GH secretion.


Secondary Outcome Measures:
  • Visceral Adipose Tissue [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Visceral adipose tissue was measured using magnetic resonance imaging at the level of the fourth lumbar vertebra (L4)


Biospecimen Retention:   Samples Without DNA

Serum and urine collected


Enrollment: 47
Study Start Date: May 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Obese girls
The inclusion criteria will be girls 12-18 years of age. According to the Centers for Disease Control and Prevention, the definition of obesity is a BMI higher than the 95th percentile for age and sex, and that of overweight is a BMI between the 85th and 95th percentiles. Cases will be defined as having a body mass index (BMI) greater than the 95th percentile for age according to the 2000 Centers for Disease Control and Prevention growth charts.
Normal-weight girls

Detailed Description:

Obesity is an epidemic that is striking people at younger ages than ever before. Obesity is associated with changes in the secretory patterns of several hormones including ghrelin, growth hormone (GH), and insulin, which have not been examined in the adolescent age group. Ghrelin, a primarily gastric hormone, increases appetite and is a GH secretagogue. This study will compare the alteration in secretion of ghrelin and GH in overweight and normal weight adolescent girls through frequent blood sampling and GH stimulation testing with growth hormone releasing hormone and arginine. The relationship between these hormones and insulin resistance, measured by 1H-nuclear magnetic resonance spectroscopy, and body composition, measured by dual energy x-ray absorptiometry and magnetic resonance imaging, will be investigated. This study will also determine the postprandial ghrelin response to test meals that vary by the type of predominant macronutrient, which may predict the degree of hunger and amount of intake at a subsequent meal. Understanding obesity-related changes in ghrelin and GH and their relationship to body composition, insulin resistance, and appetite will help in the development of strategies to reduce complications of obesity.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Obese and normal-weight girls between 12-18 years old

Criteria

Inclusion Criteria:

  1. Girls 12-18 years of age
  2. Obese subjects: BMI higher than the 95th percentile for age and sex
  3. Normal-weight controls: BMI from the 15th to the 85th percentiles for age and sex

Exclusion Criteria:

  1. History of disorders other than obesity that may affect growth hormone, ghrelin, cortisol, or insulin secretion such as eating disorder, diabetes mellitus, hypertension, thyroid disease, Cushing's syndrome, liver disease, renal failure, or an excess or deficiency of GH or cortisol
  2. Medications that could affect glucose and lipid levels or the secretion of growth hormone, ghrelin, insulin, or cortisol such as rhGH, glucocorticoids, and birth control pills
  3. Pregnancy
  4. Smoking or substance abuse
  5. Active dieting
  6. Surgical procedures for obesity
  7. Dietary restrictions such as bread, dairy, peanut, aspartame, or meat products used in the study
  8. Metal implants, including intracranial surgical clips or pacemakers
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00140842

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Anne Klibanski, MD Massachusetts General Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Anne Klibanski, MD, Laurie Carrol Guthart Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00140842     History of Changes
Other Study ID Numbers: 2004-P-002191
Study First Received: August 30, 2005
Results First Received: March 3, 2011
Last Updated: October 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Obesity, adolescent, ghrelin, growth hormone, cortisol

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014